CT-2584 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00004026
- Lead Sponsor
- CTI BioPharma
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. CT-2584 may stop the growth of prostate cancer by stopping blood flow to the tumor.
PURPOSE: Randomized phase II trial to study the effectiveness of CT-2584 in treating patients who have metastatic prostate cancer that has not responded to previous therapy.
- Detailed Description
OBJECTIVES: I. Compare the efficacy, safety, and pharmacokinetics of 2 different treatment schedules of CT-2584 in patients with hormone refractory, metastatic adenocarcinoma of the prostate.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive CT-2584 IV over 6 hours daily for 3 days every 3 weeks. Arm II: Patients receive CT-2584 IV over 6 hours once every 7 days for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 80 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Stanley Scott Cancer Center
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Our Lady of Mercy Medical Center
🇺🇸Bronx, New York, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Jonsson Comprehensive Cancer Center, UCLA🇺🇸Los Angeles, California, United States